JP6041879B2 - Biopsy device tissue specimen holder with bulk chamber and pathological chamber - Google Patents

Description

Disclosure details

〔background〕
Biopsy specimens have been obtained in a variety of ways in a variety of medical procedures using a variety of devices. The biopsy device can be used under stereotactic guidance, ultrasound guidance, MRI guidance, PEM guidance, BSGI guidance, or others. For example, some biopsy devices can be fully operated by a user with one hand and can capture one or more biopsy specimens from a patient with a single insertion. In addition, some biopsy devices include vacuum modules, for example, for communication of fluids (eg, pressurized air, saline, air, vacuum, etc.), for power transmission, and / or for communication such as commands. And / or connected to a control module. Other biopsy devices may be fully or at least partially operable without being connected or otherwise connected to another device.

  An merely exemplary biopsy device is disclosed below: US Pat. No. 5,526,822 issued Jun. 18, 1996 under the name “Method and Apparatus for Automated Biopsy and Collection of Soft Tissue”. No .; US Pat. No. 6,086,544 issued July 11, 2000 under the name “Control Apparatus for an Automated Surgical Biopsy Device”; September 2003, under the name “MRI Compatible Surgical Biopsy Device” U.S. Patent No. 6,626,849 issued on the same day; U.S. Patent Application Publication No. 2006/0074345 published April 6, 2006 under the name "Biopsy Apparatus and Method"; "Remote Thumbwheel for a Surgical US Pat. No. 7,442,171 issued on Oct. 28, 2008 under the name “Biopsy Device”; published on September 4, 2008 under the name “Presentation of Biopsy Sample by Biopsy Device” U.S. Patent Application Publication No. 2008/0214955; U.S. Pat. No. 7,854,706 issued Dec. 21, 2010 under the name "Clutch and Valving System for Tetherless Biopsy Device"; "Hand Actuated Tetherless Biopsy" US Patent Application Publication No. 2010/0152610 published on June 17, 2010 under the name “Device with Pistol Grip”; US Patent published on June 24, 2010 under the name “Biopsy Device with Central Thumbwheel” Published application 2010/0160819; US patent application publication 2010/0160824 published June 24, 2010 under the name “Biopsy Device with Discrete Tissue Chambers”; under the name “Tetherless Biopsy Device with Reusable Portion” US Patent Application Publication No. 2010/0317997, published December 16, 2010; “Handheld Biopsy Device wit US Non-provisional Patent Application No. 12 / 953,715 filed on November 24, 2010 under the name “H Needle Firing”; filed on April 14, 2011 under the name “Biopsy Device with Motorized Needle Firing” US non-provisional patent application 13 / 086,567. The disclosures of each of the above listed US patents, US patent application publications, and US non-provisional patent applications are hereby incorporated by reference.

  Several systems and methods have been made and used to obtain biopsy specimens, but we believe that no one has made or used the claimed invention prior to the inventors.

  While the specification concludes with claims that particularly point out and distinctly claim the invention, it is believed that the present invention will be better understood from the following description of specific embodiments, taken together with the accompanying drawings. It is done. In the accompanying drawings, like reference characters identify the same elements. In the drawings, some components, or some of the components, are shown in perspective, as depicted by dashed lines.

  The drawings are in no way intended to be limiting, and it is contemplated that various embodiments of the invention may be implemented in a variety of other ways, including those not necessarily depicted in the drawings. ing. The accompanying drawings, which are incorporated in and form a part of this specification, illustrate several aspects of the present invention and, together with the description, serve to explain the principles of the invention. It is understood that the present invention is not limited to the exact configuration.

[Detailed explanation]
The following description of specific embodiments of the present invention should not be used to limit the scope of the present invention. Other examples, features, aspects, embodiments, and advantages of the present invention will be apparent to those skilled in the art from the following description. The following description is, by way of example, one of the best ways contemplated for carrying out the invention. It will be appreciated that the invention is capable of other different and obvious aspects that do not depart from the invention. Accordingly, the drawings and descriptions are to be regarded as illustrative in nature, and not as restrictive.

I. Exemplary Biopsy Device Overview As shown in FIG. 1, an exemplary biopsy system (2) includes a biopsy device (10) and a vacuum control module (1400). As shown in FIGS. 3-4, the biopsy device (10) includes a probe (100), a holster (700), and a tissue specimen holder (300). As described in more detail below, and as shown in FIG. 4, the probe (100) can be disconnected from its corresponding holster (700).

  By way of example only, probe (100) may be provided as a disposable component and holster (700) may be provided as a reusable component. The vacuum control module (1400) is provided on a cart (not shown) in this example, but like other components described herein, the cart is merely an option. In order to provide electrical and mechanical communication to the biopsy device (10) and to provide electrical communication with the vacuum control module (1400), a control module interface (not shown) is connected to the biopsy device (10) and a vacuum. It may be provided between the control module (1400). By way of example only, the control module (1400) is disclosed in U.S. Patent Application Publication No. 2008/2008 published September 4, 2008 under the name “Presentation of Biopsy Sample by Biopsy Device”, the disclosure of which is incorporated herein by reference. May be constructed and operable in accordance with at least a portion of the teachings of / 0214955. Among other components described herein, foot switches (not shown) and / or other devices are used to provide at least some control of at least a portion of the biopsy system (2). obtain. As shown in FIG. 1, the conduit (1200) allows force (eg, mechanical power through cable, power, pneumatic power, etc.), control signal, salt from the vacuum control module (1400) to the biopsy device (10). Provides transmission of water, vacuum, and aeration. Each of these components is described in further detail below.

  2-4 show an exemplary biopsy device (10). As described above, the biopsy device (10) of this embodiment includes the probe (100) and the holster (700). Referring to FIGS. 3-4, a needle (110) extends distally from probe (100) and is inserted into a patient's tissue to obtain a tissue specimen, as described in more detail below. . These tissue specimens are deposited in a tissue specimen holder (300) at the proximal end of the probe (100), as will also be described in more detail below. The use of the term “holster” herein should not be read as requiring any portion of the probe (100) to be inserted into any portion of the holster (700). I want you to understand. In this embodiment, as shown in FIG. 4, a protrusion (102) is used to removably secure the probe (100) to the holster (700), although various other types of structures, components , Features, etc. (eg, bayonet mounts, latches, clamps, clips, snap fittings, etc.) provide a removable connection between the probe (100) and the holster (700). It should be understood that it can be used for: Furthermore, in some biopsy devices (10), the probe (100) and holster (700) may be of an integral or integrated structure so that these two components cannot be separated. ing. By way of example only, in a version in which probe (100) and holster (700) are provided as separable components, probe (100) may be provided as a disposable component, and holster (700) is reusable. It may be provided as a component. Still other suitable structural and functional relationships between probe (100) and holster (700) will be apparent to those skilled in the art in view of the teachings herein.

  Some variants of the biopsy device (10) may include one or more sensors (not shown) in the probe (100) and / or in the holster (700), the sensor ( 100) is configured to detect when coupled to holster (700). Such sensors or other features may be further configured to allow only certain types of probes (100) and holsters (700) to be coupled together. Additionally or alternatively, such a sensor disables one or more functions of the probe (100) and / or holster (700) until the appropriate probe (100) and holster (700) are coupled together. Can be configured. Of course, such sensors and features may be modified or omitted as desired.

  In some versions, as shown in FIG. 2, the biopsy device (10) includes a vacuum source (800), such as a vacuum pump. By way of example only, the vacuum source (800) may be incorporated into the probe (100), incorporated into the holster (700), and / or a completely separate component. In a version where the vacuum source (800) is separate from the probe (100) and the holster (700), the vacuum source (800) is (in the embodiment of FIG. 1 as a vacuum control module (1400) and a conduit (1200). The probe (100) and / or holster (700) may be coupled by one or more conduits such as flexible tubes (1402, 1408) as shown and described in more detail below. As shown in FIG. 2, the vacuum source (800) is in fluid communication with the tissue specimen holder (300) and the needle (110). Thus, the vacuum source (800) can be actuated to draw tissue into the needle (110) or the side hole (114) of the needle portion. The tissue specimen holder (300) is also in fluid communication with the cutter (200). Thus, the vacuum source (800) can also be actuated to draw the cut tissue specimen through the hollow interior of the cutter (200) and into the tissue specimen holder (300). Other suitable ways in which the vacuum source (800) may be used will be apparent to those skilled in the art in view of the teachings herein. It should also be understood that the vacuum source (800) can simply be omitted if desired.

  In some versions, a vacuum source (800) is provided in accordance with the teachings of US Patent Application Publication No. 2008/0214955, the disclosure of which is incorporated by reference above. Additionally or alternatively, a vacuum source (800) may be provided in accordance with the teachings of US Non-Provisional Patent Application No. 12 / 953,715, the disclosure of which is incorporated by reference above. As yet another exemplary embodiment, a vacuum source (800) was filed on February 22, 2010 under the name “Biopsy Device with Auxiliary Vacuum Source,” the disclosure of which is incorporated herein by reference. May be provided in accordance with the teachings of US Non-Provisional Patent Application No. 12 / 709,695. Still other suitable methods that can provide the vacuum source (800) will be apparent to those skilled in the art in view of the teachings herein.

  The biopsy device (10) of the present embodiment is configured to be installed on a table or a fixed object, and is used under stereotactic guidance. Of course, the biopsy device (10) could alternatively be used under ultrasound guidance, MRI guidance, PEM guidance, BSGI guidance or otherwise. It should also be understood that the biopsy device (10) can be sized and configured such that the biopsy device (10) can be operated with one hand of the user. Specifically, the user can grab the biopsy device (10), insert the needle (110) into the patient's breast, and collect one or more tissue samples from within the patient's breast. All with one hand. Alternatively, the user can grab the biopsy device (10) with two or more hands and / or with any desired help. In some circumstances, the user can capture multiple tissue specimens with only one insertion of the needle (110) into the patient's breast. Such tissue specimens can be pneumatically deposited in the tissue specimen holder (300) and then retrieved from the tissue specimen holder (300) for analysis. While the embodiments described herein often refer to obtaining biopsy specimens from a patient's breast, the biopsy device (10) may be used in a variety of other procedures for a variety of other purposes. It should also be understood that it can be used in various other parts of the patient's anatomy (eg, prostate, thyroid, etc.). Various exemplary components, features, configurations, and operability of the biopsy device (10) are described in further detail below, but other suitable components, features, configurations, and operability are described below. It will be apparent to those skilled in the art in view of the teachings herein.

  As shown in FIG. 1, an exemplary vacuum canister (1500) is configured to be coupled to a vacuum control module (1400). The vacuum control module (1400) is operable to induce a vacuum through the vacuum canister (1500), and such a vacuum can be communicated to the biopsy probe (100). For example, the vacuum control module (1400) can transmit the vacuum through the tube (1404), which in turn passes through the tissue specimen holder (300) and the probe (100) as described below. A vacuum can be transmitted to the cutter lumen (not shown). The vacuum control module (1400) can also transmit vacuum through the tube (1402) to the hub member or hub (150) manifold, as shown in FIGS. , To the vacuum lumen (not shown) of the outer cannula (111) of the needle (110).

  Furthermore, the vacuum canister (1500) is operable to collect fluid sent from the biopsy probe (100) during use of the biopsy probe (100). Thus, the vacuum canister (1500) can be viewed as providing a fluid interface between the biopsy probe (100) and the vacuum control module (1400). US Patent Application Publication No. 2008/0214955, published September 4, 2008 under the name “Presentation of Biopsy Sample by Biopsy Device,” the disclosure of which is incorporated herein by reference, and “Biopsy Device with Discrete Tissue” Any suitable vacuum control module and vacuum canister may be used, such as those described in US Patent Application Publication No. 2010/0160824, published June 24, 2010 under the name “Chambers”. In addition, any other suitable component, system, technology, or device can be used with a suitable control module or vacuum canister.

  As shown in FIG. 1, the tube (1408) is fed into the tube (1402). Tube (1410) is also fed into tube (1402). Specifically, the connector (1446) connects the saline tube (1408) to the tube (1402). As shown, connector (1446) is provided adjacent to canister (1500), and connector (1448) is provided near biopsy probe (100). In this example, connectors (1446, 1448) simply provide a conduit that is always open between tube (1410, 1402) and tube (1408, 1402), respectively. In some other versions, the connectors (1446, 1448) may have any other suitable component (eg, a valve, etc.). Disclosure herein that the configuration of the tubes (1402, 1408, 1410) and connectors (1446, 1448) allows either vacuum, vent, or saline to be communicated through the tube (1402). Will be understood by considering. An exemplary determination of which of these to communicate through the tube (1402) is described in further detail below. Also, as shown, the saline bag (1444) is coupled to the tube (1408) using any suitable conventional fitting.

  The vacuum control module (1400) of this example may also include a controller (1480) operable to control the motor of the holster (700). By way of example only, control module (1400) is disclosed in US Pat. No. 7,938, issued May 10, 2011 under the name “Vacuum Timing Algorithm for Biopsy Device,” the disclosure of which is incorporated herein by reference. It may be constructed and operable according to at least part of the teachings of 786. Other suitable methods that can provide vacuum, saline, other fluids and / or controls will be apparent to those skilled in the art in view of the teachings herein.

II. Exemplary Probe As shown in FIGS. 2-4, the probe (100) of this example includes a distally extending needle (110). The probe (100) also includes a chassis (120) and an upper housing (130), which are secured to each other. As best seen in FIG. 4, the gear (140) is exposed through the opening (142) of the chassis (120) to drive the cutter actuation mechanism (202) (FIG. 2) of the probe (100). It is possible to operate. As can also be seen in FIG. 4, another gear (144) is exposed through another opening (146) in the chassis (120) and is operable to rotate the needle (110). The gear (140) of the probe (100) meshes with the exposed gear (740) of the holster (700) when the probe (100) and the holster (700) are coupled together. Similarly, the gear (144) of the probe (100) meshes with the exposed gear (744) of the holster (700) when the probe (100) and the holster (700) are coupled together.

  As described in more detail below, the tissue specimen holder (300) is removably secured to the posterior member of the probe (100), but the tissue specimen holder (300) is instead attached to the probe (100). It may be fixed to some other component. As described above, although not shown in FIGS. 2-4, a pair of tubes (1402, 1404) are coupled to the probe (100) to provide fluid communication with the probe (100).

  Suitable configurations of the probe (100) will be apparent to those skilled in the art in view of the teachings herein. For example, probe (100) is disclosed in US Patent Application Publication No. 2008/0214955, published September 4, 2008 under the name “Presentation of Biopsy Sample by Biopsy Device,” the disclosure of which is incorporated herein by reference. Can be configured according to any of the teachings of Other methods by which the probe (100) can be constructed are disclosed below: published June 24, 2010 under the name “Mechanical Tissue Sample Holder Indexing Device”, the disclosure of which is incorporated herein by reference. Published US Patent Application No. 2010/0160816; the disclosure of which is incorporated herein by reference, US Patent Application Publication No. 2010 published 24 June 2010 under the name “Biopsy Device With Sliding Cutter Cover”. U.S. Patent Application Publication No. 2010/0160819 published on June 24, 2010 under the name “Biopsy Device with Central Thumbwheel”, the disclosure of which is incorporated herein by reference; US non-provisional patent application filed April 14, 2011 under the name of “Biopsy Device with Motorized Needle Firing” 13 / 086,567; and / or US Patent Application Publication No. 2010/2010 published June 24, 2010 under the name “Biopsy Device with Discrete Tissue Chambers”, the disclosure of which is incorporated herein by reference. No. 0608824. Still other ways in which the probe (100) can be formed, including alternative techniques, materials and configurations, will be apparent to those skilled in the art in view of the teachings herein.

A. Exemplary Needle The needle (110) of this example includes a penetrating tip (112), a side hole (114) located proximal to the tip (112), and a hub member (150). The tissue penetrating tip (112) does not require a large amount of force, and it is not necessary to pre-form an opening in the tissue before insertion of the tip (112), and is configured to penetrate and penetrate the tissue. Is done. Alternatively, the tip (112) may not be pointed (eg, rounded, flat, etc.) as desired. The tip (112) may also be configured to provide greater echogenicity than other portions of the needle (110), increasing the visibility of the tip (112) under ultrasound imaging. By way of example only, the tip (112) is a U.S. non-provisional application filed on Sep. 3, 2010 under the name "Echogenic Needle for Biopsy Device," the disclosure of which is incorporated herein by reference. 875,200 may be configured according to any of the teachings. Other suitable configurations that may be used for the tip (112) will be apparent to those skilled in the art in view of the teachings herein.

  The lateral hole (114) is sized to receive tissue that has escaped during operation of the device (10). A hollow tubular cutter (200) with a sharp distal edge (not shown) is located inside the needle (110). The cutter (200) is operable to rotate and translate relative to the needle (110), cut the tissue specimen from tissue passing through the side hole (114) and protruding through the side hole (114). is there. For example, the cutter (200) can move from an extended position to a retracted position, thereby “opening” the side hole (114) to project tissue through the side hole and then extending from the retracted position. Returning to the exit position, the protruding tissue can be cut. Although the side hole (114) is illustrated in FIG. 3 with its upper position oriented, the needle (110) can be moved to any side of the needle (110) around the longitudinal axis of the needle (110). It should be understood that it can be rotated to a desired angular position. Such rotation of the needle (110) is facilitated by the hub member (150) in this example.

  The hub member (150) of this example may be overmolded around the needle (110), and the hub member (150) and the needle (110) rotate and translate integrally with each other. By way of example only, the needle (110) may be formed from metal and the hub member (150) is overmolded around the needle (110) to secure the hub member (150) integrally to the needle (110). It may be formed of a plastic material. Hub member (150) and needle (110) may instead be formed of any other suitable material and may be secured together in any other suitable manner. The hub member (150) includes an annular flange (152) and a finger-operated circular plate (154). The gear (144) is slidably and coaxially disposed on the proximal portion (150) of the hub member (150), is keyed to the hub member (150), and is rotated by rotation of the gear (144). 150) and needle (110) rotate, but hub member (150) and needle (110) are not able to translate relative to gear (144). The gear (144) is rotatably driven by the gear (744). Alternatively, the needle (110) can be rotated by rotating the finger-rotating circular plate (154). Various other suitable methods by which the needle (110) can be manually rotated will be apparent to those skilled in the art in view of the teachings herein. It is also understood that the rotation of the needle (110) can be automated in a variety of ways, including but not limited to the various forms of automatic needle rotation described in the various references cited herein. I want to be. The needle (110) can be translated longitudinally relative to the chassis (120) and the upper housing (130), in particular by a needle firing mechanism (400) (FIG. 2), for example.

  As with the other components described herein, needle (110) may be altered, modified, replaced, or supplemented in various ways, and needle (110) may have various alternative features. It should be understood that components, configurations, and functionality may be included. A plurality of outer openings (not shown) may be formed in the needle (110) and may be in fluid communication with a lumen (not shown). For example, such an outer opening is described in U.S. Patent No. 7,918, issued April 5, 2011 under the name "Biopsy Device with Vacuum Assisted Bleeding Control," the disclosure of which is incorporated herein by reference. It may be configured in accordance with the teachings of No. 804. The cutter (200) may include one or more side openings (not shown). Of course, like the other components described herein, such outer openings in the needle (110) and cutter (200) are merely optional. As another merely illustrative example, needle (110) is a United States published September 4, 2008 under the name "Presentation of Biopsy Sample by Biopsy Device," the disclosure of which is incorporated herein by reference. It may be constructed and operable in accordance with the teachings of Patent Application Publication No. 2008/0214955 and / or according to the teachings of any other references cited herein.

  The probe (100) may also include a valve assembly in fluid communication with at least a portion of the needle (110), the valve assembly being in any suitable state, such as the longitudinal position of the cutter (200). Based on this, the pneumatic state of at least a portion of the needle (110) is selectively changed. By way of example only, such a valve assembly is disclosed in U.S. Patent Application Publication No. 2010 published on December 16, 2010 under the name "Tetherless Biopsy Device with Reusable Portion," the disclosure of which is incorporated herein by reference. No. 12/30, filed on Nov. 24, 2010 under the name “Handheld Biopsy Device with Needle Firing”, the disclosure of which is hereby incorporated by reference. May be constructed and operable in accordance with the teachings of 953,715 or otherwise. Additionally or alternatively, valving is a published US patent application published on September 4, 2008 under the name “Presentation of Biopsy Sample by Biopsy Device,” the disclosure of which is incorporated herein by reference. It may be provided by a vacuum source (800) (FIG. 2) and / or a vacuum canister, such as those taught in 2008/0214955. Other suitable alternative versions, features, components, configurations and functionality of the needle (110) will be apparent to those skilled in the art in view of the teachings herein.

B. Exemplary Cutter Actuation Mechanism As noted above, the cutter (200) rotates and translates with respect to the needle (110) and passes through the side hole (114) and protrudes through the side hole (114). Is operable to cut a tissue specimen from. This action of the cutter (200) is provided by the cutter actuation mechanism (202). Although the cutter actuation mechanism (202) is primarily positioned within the probe (100) in this embodiment, the cutter actuation mechanism (202) is within the holster (700) and / or the probe (100) and the holster (700). It should be understood that it may be positioned primarily within both. The cutter actuation mechanism (202) includes meshing gears (140, 740), which are driven by a motor (204). Although the motor (204) is located in the holster (700) in this example, it is understood that the motor (204) may alternatively be located in the probe (100) and / or elsewhere. I want.

  By way of example only, the cutter actuation mechanism (202) may be constructed and operable in accordance with the teachings of US Patent Application Publication No. 2008/0214955, the disclosure of which is incorporated by reference above. By way of example only, the cutter actuation mechanism (202) may be constructed and operable in accordance with the teachings of US Patent Application Publication No. 2010/0317997, the disclosure of which is incorporated by reference above. As yet another exemplary embodiment, the cutter actuation mechanism (202) is named 18 November 2010 under the name “Tetherless Biopsy Device with Self-Reversing Cutter Drive Mechanism”, the disclosure of which is incorporated herein by reference. It can be constructed and made operable in accordance with the teachings of US Patent Application Publication No. 2010/0292607 published to date. Alternatively, the cutter actuation mechanism (202) may be constructed in accordance with the teachings of any other reference cited herein. The biopsy device (10) may prevent the cutter (200) from translating (eg, the cutter (200) simply rotating) or the cutter (200) (eg, the cutter (200) It should also be understood that it may be configured to simply translate, etc.). As another merely illustrative example, cutter (200) may be pneumatically operated in addition to or instead of being actuated by mechanical components. Other suitable alternative versions, features, components, configurations, and functionality of the cutter actuation mechanism (202) will be apparent to those skilled in the art in view of the teachings herein.

C. Exemplary Cutter A hollow cutter (200) is disposed within the cannula lumen of the outer cannula (111) in this example. The interior of the cutter (200) defines a cutter lumen, and fluid and tissue can be routed through the cutter (200) via the cutter lumen. As described in more detail below, the cutter (200) is configured to rotate within the cannula lumen of the outer cannula (111) and to translate axially within the cannula lumen of the outer cannula (111). Is done. Specifically, the cutter (200) is configured to cut a biopsy specimen from tissue protruding through the lateral hole (114) of the outer cannula (111). As described in further detail below, the cutter (200) is further configured so that the cut tissue specimen can be fed proximally through the cutter lumen. An merely illustrative example of such cutting and sending proximally is 1996 under the name “Method and Apparatus for Automated Biopsy and Collection of Soft Tissue”, the disclosure of which is incorporated herein by reference. As described in US Pat. No. 5,526,822 issued Jun. 18, but any other suitable structure or technique cuts the tissue specimen within the biopsy system (2), and Can be used to send. Still other ways in which the cutter (200) can be constructed or handled, including alternative techniques and materials, will be apparent to those skilled in the art in view of the teachings herein.

D. Exemplary Tissue Specimen Holder The tissue specimen holder (300) of this example, described in further detail below, includes an outer cup (303) and a rotatable manifold or inner housing (304) and is rotatable. The manifold or inner housing (304) includes a plurality of chambers configured to receive tissue specimens cut by the cutter (200) and fed proximally through the hollow interior of the cutter (200). The tissue specimen holder (300) also includes one or more removable trays that allow the user to cut without having to remove the tissue specimen holder (300) from the chassis (120). The tissue specimen can be removed from the tissue specimen holder (300). The tissue specimen holder (130) may further include an inner housing or rotatable manifold, as described in detail below, where the inner housing or rotatable manifold includes a vacuum source (800) and a cutter (200). And is rotatable to index the chamber continuously with respect to the cutter (200). Specifically, the manifold is rotated by a tissue specimen holder rotating mechanism (302) driven by a motor (301). At least a portion of the tissue specimen holder rotation mechanism (302) and / or motor (301) is incorporated into the probe (100), the holster (700), or both the probe (100) and the holster (700). Please understand that you get. It should also be understood that some versions of the tissue specimen holder (300) may be driven manually, pneumatically or otherwise.

  By way of example only, tissue specimen holder (300) may be constructed and operable according to the teachings of US Patent Application Publication No. 2008/0214955, the disclosure of which is incorporated by reference above. By way of example only, tissue specimen holder (300) was published on June 24, 2010 under the name “Biopsy Device with Discrete Tissue Chambers”, the disclosure of which is incorporated herein by reference. It may be constructed and enabled according to the teachings of US Patent Application Publication No. 2010/0160824. As yet another merely illustrative example, a tissue specimen holder (300) is a U.S. patent published on September 11, 2008 in the name of "Biopsy Sample Storage", the disclosure of which is incorporated herein by reference. It may be constructed and enabled according to the teachings of published application 2008/0221480.

  The outer cup (303) of the examples disclosed herein has a cylindrical shape that defines a distal end and a proximal end, although any other suitable shape or configuration can be used. . The outer cup (303) is configured to engage the probe (100) in a bayonet fashion and the outer cup (303) is selectively removed from the probe (100), or It can be fixed to the probe. More specifically, the distal end of the outer cup (303) engages a protrusion (not shown) of the probe (100) when the outer cup (303) is fully rotated relative to the probe (100). A plurality of slots (305) that may be included. Other suitable configurations that provide selective engagement between the outer cup (303) and the probe (100) will be apparent to those skilled in the art in view of the teachings herein. Further, the cup (303) remains stationary while the housing (304) rotates within the cup (303). The cup (303) can also provide an additional seal to the tissue specimen holder (302) as a whole. However, it should be understood that like other components described herein, the cup (303) is merely optional and may be omitted or changed in several ways as desired. Still other suitable methods by which the tissue specimen holder (300) can be constructed and made operable will be apparent to those skilled in the art in view of the teachings herein.

III. Exemplary Holster As shown in FIGS. 3-4, the holster (700) of this example includes an upper housing cover (702), a side panel (704), and a housing base (706), which are secured together. It is fixed. As best seen in FIG. 4 and as described above, the gears (740, 744) are exposed through the upper housing cover (702), and the probe (100) and holster (120) are coupled together. And the gears (140, 144) of the probe (100). Specifically, the gears (740, 140) drive the cutter actuation mechanism (202) and the gears (744, 144) are used to rotate the needle (110). As described in further detail below, the holster (700) also includes a firing rod (730) and a bifurcation (732) that are coupled to the needle (110) to move the needle (110) distally. Fire.

  All motors (204, 304, 402) referred to herein are housed within holster (700) in this example and receive power from an external power source via cable (720). Additionally or alternatively, data can be communicated from and / or to holster (700) via cable (720) as desired. In some other versions, the motors (204, 304, 402) are powered by one or more batteries located within the holster (700) and / or probe (100). Thus, it should be understood that the cable (720) is merely optional, as are the other components described herein. As just another exemplary variant, the motor (204, 304, 402) may be pneumatically powered and the cable (720) is replaced with a conduit that delivers a pressurized fluid medium to the holster (700). May be. As yet another merely exemplary variation, cable (720) may include one or more rotational drive cables driven by motors (204, 304, 402) located external to holster (700). It should also be understood that two or three of the motors (204, 304, 402) can be combined as a single motor. Other suitable ways in which the various mechanisms (202, 302, 400) can be driven will be apparent to those skilled in the art in view of the teachings herein.

A. Exemplary Needle Rotation Mechanism As described above, rotation of gear (744) causes needle (110) to rotate relative to probe (100). In this example, gear (744) is rotated by rotating knob (710). Specifically, the knob (710) is connected to the gear (744) by a series of gears (not shown) and a shaft (not shown), and the rotation of the knob (710) rotates the gear (744). A second knob (710) extends from the other side of the holster (700). By way of example only, such a needle rotation mechanism can be constructed in accordance with the teachings of US Patent Application Publication No. 2008/0214955, the disclosure of which is incorporated herein by reference. By way of example only, a needle rotation mechanism may be constructed according to the teachings of US 2010/0160819, the disclosure of which is incorporated by reference above. In some other versions, the needle (110) is rotated by a motor. In still other versions, the needle (110) is simply rotated by rotating the finger-rotating circular plate (154). Various other suitable ways in which the needle (110) can be rotated will be apparent to those skilled in the art in view of the teachings herein. It should also be understood that some versions may not result in rotation of the needle (110).

B. Exemplary Needle Firing Mechanism The holster (700) of this example further includes a needle firing mechanism (400) operable to fire the needle (110) from the loading position. By way of example only, such firing may occur when the biopsy device (10) is mounted on a stereotactic fixture or other fixture with the tip (112) adjacent to the patient's breast. The needle firing mechanism (400) may be actuated to drive the needle (110) into the patient's breast. The needle firing mechanism (400) drives the needle (110) along any suitable range of motion and moves the tip (112) to any suitable distance relative to the fixed component of the probe (100). Can be configured to drive up to. The needle firing mechanism (400) of the present embodiment is actuated by an activation button (760) and an arming buttons (750). Actuation button (760) includes a membrane switch placed on side panel (704) of holster (700). In some versions, the activation button (760) is on both sides of the holster (700), while in other versions, the activation button (760) is only on one side of the holster (700) or other Located in a location (eg, remote user interface, vacuum source (800) or other location). The activation button (760) is operable to selectively activate the motor (402) for loading the needle firing mechanism (400). The preparation buttons (750) are also provided on both sides of the holster (700) in this embodiment, and can be mechanically moved in the lateral direction with respect to the side panel (704). Each ready button (750) includes a bellows (752) that provides a fluid tight seal with the side panel (704). Of course, any type of button (750, 760) may have various other components, features, configurations and functionality.

  In this example, the needle firing mechanism (400) is coupled to the needle (110) via the firing rod (732) and the firing bifurcation (732). Firing rod (732) and firing bifurcation (734) are secured together by complementary flats and pins (738). The firing bifurcation (732) includes a pair of protrusions (734) that receive the hub member (150) of the needle (110) therebetween. The protrusion (734) is positioned between the annular flange (152) and the fingerwheel plate (154), and the needle (110) translates integrally with the firing rod (730) and the bifurcation (732). . Nonetheless, the protrusion (734) removably receives the hub member (50) and the bifurcation (732) is configured so that the hub member (150) is coupled when the probe (100) is coupled to the holster (700). The hub member (150) can be easily removed from the bifurcation (732) when the probe (100) is removed from the holster (700). The protrusion (734) also allows the hub member (150) to rotate between the protrusions (734), for example when the knob (710) is rotated to change the angular orientation of the side holes (114). Configured. Other suitable components, configurations, and relationships will be apparent to those skilled in the art in view of the teachings herein. By way of example only, needle firing mechanism (400) is a US non-provisional patent application filed April 14, 2011 under the name “Biopsy Device with Motorized Needle Firing”, the disclosure of which is incorporated herein by reference. May be constructed and operable in accordance with at least a portion of the teachings of 13 / 086,567. Various other suitable methods by which the needle firing mechanism (400) can be fired will be apparent to those skilled in the art in view of the teachings herein. It should also be understood that some versions may not result in firing of the needle (110).

IV. Exemplary First Version of Inner Housing for Tissue Specimen Holder FIGS. 5-8 illustrate an exemplary first of the inner or inner housing (304A) of the tissue specimen holder (300) of the biopsy device (10). Indicates the version. FIG. 5 shows an exemplary inner housing (304A) as including a bulk chamber (308) and a tray receiving / tissue specimen chamber (345A). The exemplary inner housing (304A) is positioned over a tissue specimen entry point or port (306) disposed at the distal end of the probe (100) through which a tissue specimen can be received. FIG. 5 also shows a vacuum port (307) located at the distal end of the probe (100). Inner housing (304A) is in fluid communication with vacuum source (800) by a vacuum port (307). The vacuum is transferred from the vacuum source (800) through the port (307) and then through the tissue specimen holder (300) to the port (306). With such transmission, tissue is drawn through the lumen of the cutter (200), through the exit port (306), and then into the tissue specimen holder (300).

  The inner housing (304A) is within the outer cup (303) of the tissue specimen holder (300) to index the tissue specimen chamber (345A) or bulk chamber (308) relative to the port (306) and cutter (200). It can be rotated. Additionally or alternatively, the outer cup (303) may be omitted and the inner housing (304A) may be rotated manually or automatically to index the tissue specimen chamber (345A) relative to the cutter (200). For example, the rotation is arranged in the probe (100) and / or the holster (700) and is connectable with the intermeshing gears of the probe (100) and the holster (700) operated by a motor, the shaft (422) ( It can be provided by a motor (301) via a gear shaft, such as FIG. Rotation of the inner housing of other embodiments of the present disclosure may be effected as well.

  As an example of rotation, the tissue specimen chamber (345A) of FIG. 5 may be placed on the port (306), rotating in the direction of arrow (A) and in the opposite direction. Alternatively, multiple tissue specimens can be received within the tissue specimen chamber (345A). Alternatively, the tissue specimen chamber (345A) of FIG. 5 may be rotated to a position where the tissue specimen chamber (345A) is not disposed on the port (306), so that one or more tissue specimens are transferred to the port (306). ) Through the bulk chamber (308). The vacuum port (307) of the probe (100) has a filter or screen to prevent tissue from blocking the vacuum port (307) when the bulk chamber (308) is indexed relative to the port (306). May be included. Additionally or alternatively, the probe (100) can be passed through the vacuum port (307) to remove debris from the vacuum port (307) and / or to clean the filter / screen located at the vacuum port (307). A pressure pump can be included or communicated with the pressure pump to provide positive air pressure. It should also be appreciated that the cup (303) may include a sump feature, such as for removing excess fluid.

  Referring to FIG. 6, the inner housing (304A) includes an outer annular ridge (316) that projects laterally from an outer wall (312), an inner wall (314), and an outer annular wall (310). Includes a wall (310). The outer annular ridge (316) includes an inner wall defining a notch (318), which is shown in this example as having a square shape, but a circular or triangular shape or a combination thereof Other shapes may be included, including Further, although the ridge (316) is illustrated as including a single notch (318), the ridge (316) includes a plurality of notches (318) of similar or different shape and / or size. May be included. The notch (318) may receive a corresponding protrusion of the rotation assisting member of the probe (100) described above, for example, to assist rotation of the inner housing (304A) relative to the probe (100) and / or holster (700). it can.

  The inner housing (304A) includes a tissue specimen chamber (345A) and a bulk chamber (308) separated by walls (320, 322, 324). As shown in FIG. 7, the inner surface of the wall (320, 322, 324) faces the first part (326) of the inner wall surface (314) of the outer annular wall (310), and the first part (326) along with a tissue specimen chamber (345A). The outer surface of the wall (320, 322, 324) faces the second part (328) of the inner wall surface (314) of the outer annular wall (310) and, together with the second part (328), the bulk chamber (308) is defined.

  The walls (320, 322) protrude inward from the inner wall surface (314) of the outer annular wall (310) of the inner housing (304A), and the wall (324) is disposed between the ends of the walls (320, 322). The Although the wall (324) is shown as an arcuately shaped inner member, the wall (324) may be formed to include any other suitable size and shape. Alternatively, the wall (324) may be omitted, and the walls (320, 322) meet at a point and form a triangular shape, as shown in FIG. 12, in the variants discussed in more detail below. .

  In this example, each of the walls (320, 322, 324) includes an upper proximal portion and a lower distal portion. The upper proximal portion (330) of the centrally located wall (324) is separated from the lower distal portion (332) of the wall (324) by a ledge (334). The lower distal portion of the inwardly projecting wall (320, 322) is separated from the wall (320, 322) by the distance that the upper and lower portions of the centrally located wall (324) are separated by a ledge (334). ) Having a width greater than the width of the upper proximal portion.

  Referring to FIG. 7, the inner surfaces of the inwardly projecting walls (320, 322) each include a front portion (F), a rear portion (R), and a lengthwise projection (336). In the embodiment shown in FIG. 7, the protrusion (336) extends inwardly from the upper portion of each of the walls (320, 324). The protrusions can alternatively or additionally extend from other walls described within the scope of the present disclosure. An elongated protrusion (336), a rear portion (R) of the inner surface of the walls (320, 322), and an inner wall surface (314) of the outer annular wall (310) for receiving and holding a removable tray (340). Defines the distal end of the tray space (338). As shown in FIG. 8, the rear portion of the inner surface of the walls (320, 322), the inner wall surface (314) of the outer annular wall (310), and the inner surface of the upper portion of the centrally located wall (324) are removed. Together, the proximal end of the tray space (338) that receives the possible tray (340) is defined.

  The tray (340) includes a handle (342) extending proximally from an arcuate elongated proximal end wall (344) having a proximal edge and a distal edge, as shown in FIG. The handle (342) allows the user to insert or remove the tray (340) from the tray space (338) and the tray (340) to the tray space (338). ) To manually rotate the inner housing (304A) when received within. A sidewall or outer tray wall (346, 348) having a proximal edge and a distal edge protrudes distally from the backside or distal edge of the proximal end wall (344). An elongated arcuate wall (350, 352) is disposed below and adjacent to the proximal end wall (344) and has substantially the same shape as the proximal end wall (344). ing. The proximal end wall (344) and the distal end of the elongated arcuate wall (350, 352) allow the tray (340) of the tissue specimen chamber (345A) to prevent potential leakage of tissue specimen fluid or tissue specimen. When received in the tray space (338), it acts as a wiper seal, providing an additional seal between the proximal end of the tray (340) and the tissue specimen chamber (345A), and the chamber (345A) Helps maintain an internal vacuum. These distal ends can form a friction fit, for example, with a wall defining a tray space (338) of the inner housing (304A). Other components of tray (340) and / or tissue specimen holder (300) may also include face seals and / or various types of elastomers to create a seal. Additionally or alternatively, the opposite peripheral ends of one or more of the walls (344, 350, 352) are at the proximal portion of the wall (320, 322). It can be received in a defined hole (354).

  An arcuately shaped floor (356) is disposed between the tray outer walls (346, 348) and includes holes (358). At the distal end, a base end wall (360) extends from the floor (356) and is disposed between the ends of the tray outer walls (346, 348). The base end wall (360) is sized to be received within the tray space (338). The base end wall (360) defines a hole (362) through which a tissue specimen can be received from the cutter (200), for example, via the port (306) as described above. The floor (356), the tray outer wall (346, 348), the back side of the wall (352), and the proximal end wall (360) define a tissue specimen receiving space (364). The holes (358) in the arcuately shaped floor (356) may be of any suitable shape and size. For example, the hole (358) may have a circular shape and is received in the tissue specimen receiving space (364) while the tissue specimen remains in the tray (340) positioned in the tray space (338). It may be of a sufficiently large size so that fluid from the tissue specimen can flow through the hole (358) to the fluid receiving space (366). As shown in FIG. 7, the front portion of the inner surface of the wall (320, 322), the elongated protrusion (336), the back side of the shelf-like projection (334), the inner surface of the distal portion of the centrally located wall (324) , And the floor (356) of the tray (340) form a fluid receiving space (366). The fluid receiving space (366) is disposed on the vacuum port (307) of the probe (100) as the housing (304A) rotates to position the tissue specimen chamber (345A) on the port (306). The fluid can then flow back through the biopsy device (10) to the tube connected to the vacuum source (800).

  In use, an initial set of tissue specimens can be received and stacked in a bulk chamber (308) that is placed on and aligned with a port (306) of the probe (100). The inner housing (304A) in which the bulk chamber (308) is disposed on the port (306) automatically receives, for example, the motor (301) as described above every time a tissue specimen is received through the port (306). Can be indexed. Finally, the inner housing (304A) is indexed to the point where the tissue specimen chamber (345A) is placed on and aligned with the port (306) instead of part of the bulk chamber (308), receive. At this point, after the first set of tissue specimens is received in the bulk chamber (308), the specimens received in the tissue specimen chamber (345A) are treated as pathological specimens, eg, for laboratory testing purposes. Well, specimens received in the bulk chamber (308) can be discarded. Similar uses may be made in any and for any of the embodiments of the inner housing of the present disclosure, in which the specimen received within the tissue specimen chamber is for further testing. Pathological specimens (eg, oncology samples stored in formalin prior to testing), and specimens received in the bulk chamber (308) can be discarded.

V. Exemplary Second Version of Inner Housing for Tissue Specimen Holder FIGS. 9-11 show another exemplary version of inner housing (304B) of tissue specimen holder (300) of biopsy device (10). Show. The exemplary inner housing (304B) is positioned on the port (306) as described above for the inner housing (304A). The reference numbers used for similar components of the inner housing (304A) are also used for the inner housing (304B). Furthermore, the similarities between the versions of this specification will not be further described. When the tray (370) is received in the tray space of the inner housing (304B), the proximal end view is similar to the proximal end view shown in FIG. 6 for the inner housing (304A). However, when viewing the inner housing (304B) distally, or if the tray (370) is not received within the tray space of the inner housing (304B), the inner housing (304B) has only one tissue specimen chamber ( It differs from the inner housing (304A) in that it includes three tissue specimen chambers (345B) rather than 345A). The inner housing (304B) also includes a bulk chamber (308). The tissue specimen chamber (345B) is separated from the bulk chamber (308) by walls (320, 322, 324). The wall (320, 322) projects inwardly from the inner wall surface (314) of the outer annular wall (310) of the inner housing (304A), and the wall (324) is between the ends of the wall (320, 322). It is arranged. Although the wall (324) is illustrated as being arcuately shaped, the wall (324) may be formed to include other shapes that will be apparent to those skilled in the art.

  The second version of the inner housing (304B) of the tissue specimen holder (300) further includes inner walls (372, 374), the inner walls (372, 374) being disposed between the inwardly extending walls (320, 322). Extending between an inner wall surface (314) of the outer annular wall (310) and a centrally located wall (324), defining three tissue specimen chambers (345B). Although three such chambers are shown in this example, a greater or lesser number of inner walls may be included to define a greater or lesser number of chambers, respectively. The inner surface and the inner wall (372) of the walls (320), (324), together with the first portion (P1) of the inner wall surface (314) of the outer annular wall (310), define a first tissue specimen chamber (345B). To do. The opposite surface of the inner wall (372), the inner surface of the centrally located wall (324), and the surface of the inner wall (374) together with the second portion (P2) of the inner wall surface (314) are the second tissue specimen. A chamber (345B) is defined. The opposite surface of the inner wall (374), the inner surfaces of the walls (322, 324), and the third portion (P3) of the inner wall surface (314) define a third tissue specimen chamber (345B). The outer surface of the wall (320, 322, 324) faces toward the fourth portion (P4) of the inner wall surface (314) and, together with this fourth portion, defines the bulk chamber (308).

  As shown in FIG. 10, and similarly to the first version, the inner surface of the walls (320, 322) protruding inward and the surfaces of the inner walls (372, 374) are respectively a front portion (F) and a rear portion. (R) and an elongated protrusion (336) extending inwardly from the upper portion of each of the walls. The elongated protrusion (336), the rear portion of the walls (320, 322, 372, 374), and the inner wall surface (314) of the outer annular wall (310) are both removable trays (370) as described below. ) Define the distal ends of three separate tray space cavities (376, 378, 380) for receiving and holding three respective projections (382, 384, 386), respectively. As shown in FIG. 11, the first portion, the second portion, and the third portion (P1, P2, and the third portion (P1, P2,. P3), as well as the inner surface of the upper portion of the centrally located wall (324), both receive the projections (382, 384, 386) of the removable tray (370), respectively, so that the tray space cavity (376, 378, 380).

  The tray (370) includes a handle (342) extending proximally from an arcuate elongated proximal end wall (344), as shown in FIG. The tray outer wall (390, 392) of the first protrusion (382), the tray outer wall (390, 392) of the second protrusion (384), and the tray outer wall (390, 392) of the third protrusion (386) are respectively Project distally from the back side of the proximal end wall (344). A pair of arcuate walls (394, 396) are disposed distal to and proximate to the proximal end wall (344) for each protrusion. The proximal end wall (344) and the outer distal end of the arcuate wall (394, 396) are the three protrusions (382, 384) of the tray (370) to prevent potential leakage of tissue specimen fluid or tissue specimen. 386) are received in tray space cavities (376, 378, 380), respectively, defined by the walls of tissue specimen chamber (345B), and the proximal end of tray (370) and tissue specimen chamber (345B). Acts as a wiper seal, providing an additional seal between the two and helps maintain a vacuum inside the chamber (345B). The distal end can form a friction fit with, for example, the walls of the tray space cavities (376, 378, 380) of the inner housing (304A). Other components of tray (370) and / or tissue specimen holder (300) may also include face seals and / or various types of elastomers to create a seal.

  A floor (398) is disposed between each set of tray outer walls (390, 392) and includes holes (404). At the distal end, each protrusion includes a base end wall (406) extending from a respective floor (398). Each base end wall (406) is disposed between the ends of the respective tray outer walls (390, 392). Each base end wall (406) is sized to be received within a corresponding tray space cavity (376, 378, 380). The proximal end walls (406) each include an inner wall defining a hole (408) through which a tissue specimen can be received, for example, from a cutter (200). For each protrusion, the floor (398), the tray outer wall (390, 392), the back side of the wall (396), and the proximal end wall (406) define a tissue specimen receiving space (410). The arcuately shaped floor (398) hole (408) is sized in the same manner as described above for the first version.

  In use, the inner housing (304B) can be indexed in the same manner as the inner housing (304A), and the bulk chamber (308) is first placed over the port (306) of the probe (100) to provide a tissue specimen. The inner housing (304B) can be indexed for each tissue specimen reception until one of the tissue specimen chambers (345B) receives the tissue specimen. In addition, the index can be determined for each tissue specimen chamber (345B) for potential pathological use, eg, for use as an oncological specimen stored in formalin prior to testing. Until the tissue sample received in the bulk chamber (308) may be discarded. Such automatic indexing into and receiving into multiple tissue specimen chambers is possible with the embodiments of the inner housing disclosed herein, including multiple tissue specimen chambers.

VI. Exemplary Third Version of Inner Housing for Tissue Specimen Holder FIGS. 12-14 show another exemplary version of inner housing (304C) for tissue specimen holder (300) of biopsy device (10). Indicates the version. The reference numerals used for similar components of the inner housing (304A, 304B) are also used for the inner housing (304C). Furthermore, the similarities between these versions will not be further described.

  Referring to FIG. 12, a proximal view of the inner housing (304C) shows a tab (412) extending laterally from the proximal surface (414) of the inner housing (304C). FIG. 13 shows that the tray (416) has been removed from the tray space of the inner housing (304B) along with the plug (418), bulk chamber cap (420), outer cup (303), and gear shaft (422). FIG. 6 shows a view of the distal side of the inner housing (304B). One way that the inner housing (304C) differs from the inner housing (304A) is that the inner housing (304C) does not include a single tray receiving chamber with the bulk chamber (308), but a bulk chamber ( 308) with two tissue specimens or tray receiving chamber (345C) and plug chamber (424).

  The bulk chamber cap (420) is configured to match the shape of the bulk chamber (308) to seal the bulk chamber (308). The bulk chamber cap (420) includes a recessed portion having a corresponding shape with an outline defined by the walls (320, 322, 324). The cap (420) includes a proximal surface (426) (FIG. 14) and a distal surface (428) (FIG. 13) and three walls (430) disposed between these proximal and distal surfaces. 432, 434). As shown in FIG. 16, a first longitudinal wall (430) extends from the distal surface (428) to the lateral wall (432). The lateral wall (432) extends laterally between the first longitudinal wall (430) and the second longitudinal wall (434). The second longitudinal wall (434) extends from the proximal surface (426) of the cap (420). The first longitudinal wall (430) is shaped to be adjacent to the inner wall surface (314) of the inner housing (304C) and the outer surface of the walls (320, 322, 324). The lateral wall (432) of the cap (420) is shaped adjacent to a portion of the proximal surface (414) and tab (412) of the inner housing (304C). When the cap (420) is disposed on the inner housing (304C), the cap (420) includes, for example, the first vertical wall (430) of the cap (420) and the inner wall surface (314) of the inner housing (304C). ) And the outer surface of the wall (320, 322, 324) may be connected to the inner housing (304C) with a friction fit connection. Due to the longitudinal wall (432) of the cap (420) disposed extending over the tab (412), removal of the cap (420) is sufficient to lift the cap (420) from the inner housing (304C). Part of the longitudinal wall (432) of the cap (420) when the cap (420) is installed against the inner housing (304C) so that can be added to the exposed portion of the horizontal wall (432). This can be facilitated by allowing space underneath. FIG. 14 shows the inner housing (304C) when the tissue specimen holder (300) is assembled to include a cap (420), an inner housing (304C), an outer cup (303), and a gear shaft (422). A view of the cap (420) installed in contact is shown.

  The proximal surface (426) of the cap (420) includes a handle (436) (FIG. 14) that installs the cap (420) on the inner housing (304C) or the inner housing (304C). Help remove from. The handle (436) can also be used to facilitate manual rotation of the inner housing (304C) within the outer cup (303) in a version in which the inner housing (304C) is manually rotatable. However, in this example, rotation of the inner housing (304C) is effected by the motor (301) via the shaft (422). Similar to the rotation described above for the first tissue specimen holder version, the inner housing (304C) has one of the tissue specimen chambers (345C) of FIG. 12 disposed over the port (306) as shown in FIG. Until the tissue specimen can be received in the selected tissue specimen chamber (345C). Alternatively, the inner housing (304C) is constructed in accordance with the teachings of US Patent Application Publication No. 2009/0209854 published August 20, 2009 under the name “Biopsy Method,” the disclosure of which is incorporated herein by reference. Rotate until the plug chamber (424) is placed over the specimen entry point to deliver an item or substance, eg, a marker and / or drug, by a delivery means such as a marker deployment device that can be activated and operable Can be done. The plug (418) is configured to be received within the plug chamber (424) when the marker or agent is not deployed by the deployment device, as described above, and the tissue sample is within the tissue sample chamber (345C). Acts to seal the plug chamber (424) while being received in one. Plug (418) includes a post (438) having a hole (440) extending therethrough and a handle (442) disposed at the proximal end of the post (438). The strut (438) of the plug (418) defines an elongated slot (444) that may be open to the hole (440) or access to the hole (440) by a slot door. Can be limited.

  Referring again to FIG. 12, the inner housing (304C) includes a tissue specimen chamber (345C), a plug chamber (424), and a bulk chamber (308). Tissue specimen chamber (345C) and plug chamber (424) are separated from bulk chamber (308) by walls (320, 322, 324). The walls (320, 322) protrude inward from the inner wall surface (314) of the outer annular wall (310) of the inner housing (304A), and the wall (324) is disposed between the ends of the walls (320, 322). The Although the wall (324) is illustrated as being arcuately shaped, the wall (324) may be formed to include other shapes that will be apparent to those skilled in the art.

  The inner housing (304C) of the present embodiment further includes inner walls (372, 374), and the inner walls (372, 374) are disposed between the inwardly extending walls (320, 322) of the outer annular wall (310). Extending between the inner wall (314) and the centrally located wall (324) defines two tissue specimen chambers (345B) and a plug chamber (424). In this example, two tissue specimen chambers are illustrated, but a greater or lesser number of inner walls may be included to define a greater or lesser number of tissue specimen chambers, respectively. Further, in this embodiment, a single plug chamber is illustrated, but more inner walls may be included to define a greater number of plug chambers, if desired. Also, the tissue specimen chamber is shown as having a generally trapezoidal shape and the plug chamber is shown as having an annular shape, although other shapes, sizes, and configurations for these chambers are also disclosed herein. Is within the range.

  As an alternative to the third tissue specimen chamber (345B) of the inner housing (304B), the inner housing (304C) includes an opposite surface of the inner wall (374), an inner surface of the walls (322, 324), and an inner wall surface (314). It includes an annular plug chamber (424) defined by a third portion (P3).

  The proximal portion of the centrally located wall (324) is disposed between the proximal portions of the walls (320, 322) and the distal portion of the wall (324) is a laterally extending ledge (445). And three extensions (450) project distally from the ledge (445) and extend toward the floor (446) of the central piece (448). The floor (446) extends laterally from the wall (324) and the extension (450) of the wall (324). The floor (446) includes an edge (452) that delimits an area that shows a separation line between the proximal and distal portions of the walls (320, 322), respectively. The floor (446) includes an annular portion (454) protruding from the edge (452). An annular inclined wall (456) projects distally from the annular portion (454) of the floor (446) along the distal portion of the wall (320, 322) to the sump floor (458); The drainage floor (458) includes holes (460) through which fluid or liquid is aspirated through the inner housing (304C) and removed from the inner housing (304C). Can.

  The lower distal portion of the walls (320, 322), the fourth portion (P4) of the inner wall (314) of the inner housing (304C), and the outer edge of the sump floor (458) define the space (462). Through this space (462), tissue specimens can be received into the bulk chamber (308). A strut (464) projects from the distal surface of the floor (446), as shown in FIG. The strut (464) is sized to be received within a proximal bore (not shown) of the gear shaft (422). The proximal hole is shaped and sized to receive the strut (464) in a keyed relationship. This keyed relationship allows rotation of the gear shaft (422) to rotate the strut (464), which causes the inner housing (304C) to rotate within the outer cup (303). The rotation is provided by a shaft (422) that meshes with the components of a rotating mechanism (302) driven by a motor (301). Of course, rotation may instead be effected in any other suitable manner by any other suitable component / technique.

  As shown in FIG. 13 and similar to the second version shown in FIG. 10, the inner surfaces of the inwardly projecting walls (320, 322) and the inner walls (372, 374) have a front portion (F). ), A rear portion (R), and an elongated protrusion (336) extending inwardly from the upper portion of each wall. The elongated protrusion (336), the rear portion of the walls (320, 372, 374), and the inner wall surface (314) of the outer annular wall (310) are both of the removable tray (416A) as described below. Define the distal ends of two separate tray space cavities (466, 468) for receiving and holding two respective protrusions (470, 472), respectively. As shown in FIG. 12, the opposite proximal end of the tray space cavity (466, 468) receives the protrusion (470, 472) (FIG. 13) of the removable tray (416), respectively. The proximal ends of the tray space cavities (466, 468) are the rear portions of the walls (320, 372, 374), the first and second portions (P1 and second) of the inner wall surface (314) of the outer annular wall (310). P2), as well as the inner surface of the upper part of the centrally located wall (324).

  As shown in FIG. 13, tray (416A) includes a handle (474) that extends proximally from an arcuate, elongated proximal end wall (476). The tray outer walls (478, 480) of the first protrusion (470) and the second protrusion (472) each protrude distally from the back side of the proximal end wall (476). An arcuate wall (482) is disposed distal to and proximate the proximal end wall (476) for each protrusion. The proximal end wall (476) and the outer distal end of the arcuate wall (482) are tray spaces defined by the wall of the tissue specimen chamber (345C) to prevent potential leakage of tissue specimen fluid or tissue specimen. Provide an additional seal between the proximal end of the tray (416A) and the tissue specimen chamber (345C) when the projections (470, 472) of the tray (416A) are received in the cavities (466, 468), respectively. Acts as a wiper seal and helps maintain a vacuum inside the chamber (345C). The distal end may form a friction fit with, for example, the walls of the tray space cavities (466, 468) of the inner housing (304C). Other components of tray (416A) and / or tissue specimen holder (300) may also include face seals and / or various types of elastomers to create a seal.

  A floor (484) is disposed between each set of tray outer walls (478, 480) and includes holes (486). Each protrusion includes a base end wall (488) extending from a respective floor (484) at the distal end. Each base end wall (488) is disposed between the ends of the respective tray outer walls (478, 480). Each base end wall (488) is sized to be received within a corresponding tray space cavity (466, 468). The proximal end walls (488) each include an inner wall that defines holes (490) through which tissue specimens can be received, eg, from the cutter (200). For each protrusion, the floor (484), the tray outer wall (478, 480), the back side of the arcuate wall (482), and the proximal surface of the proximal end wall (488) define a tissue specimen receiving space (492). . The arcuately shaped floor (484) hole (486) is sized in the same manner as described above for the first version of hole (358). Similarly, fluid from a tissue specimen received in a tissue specimen receiving space (492) via the port (306) of the probe (100) is a tray (416) in which the tissue specimen is positioned within the respective tray space. Can flow through the holes (486) to the respective fluid receiving spaces (494) while remaining in the respective protrusions. As shown in FIG. 13, the fluid receiving space (494) has a front portion (F) on the inner surface of the wall (322, 372, 374), an elongated protrusion (336), a back side of the shelf-like projection (445), and a center. Formed by the inner surface of the extension (450) of the distal portion of the disposed wall (324) and the floor (484) of the projections (470, 472) of the tray (416A). The fluid can then return through the biopsy device (10) via the vacuum port (307) to the tube connected to the vacuum source (800) as described above.

VII. Exemplary Fourth Version of Inner Housing for Tissue Specimen Holder FIGS. 15-16 illustrate another exemplary inner housing (304D) for tissue specimen holder (300) of biopsy device (10). Indicates the version. The reference numerals used for similar components of the inner housing (304A, 304B, 304C) are also used for the inner housing (304D). Furthermore, the similarities between these versions will not be further described.

  The inner housing (304D) differs from the inner housing (304C) in that the inner housing (304D) includes a single tissue specimen chamber (345D) with a plug chamber (424) rather than a plurality of tissue specimen chambers. Inner housing (304D) may include a proximal surface mounted against cap (420), similar to that described for inner housing (304C). FIG. 15 shows an alternative proximal surface of the inner housing (304D), where the bulk chamber (308) is disposed within the upper peripheral edge of the outer annular wall (310) of the inner housing (304D). Sealed by the upper floor (500), the tissue specimen chamber (345D) and the plug chamber (424) communicate with holes defined in the upper floor (500).

  FIG. 16 shows the distal end of the inner housing (304D). The walls (320, 502) together with the first portion of the inner wall surface (314) of the outer annular wall (310) define a tissue specimen chamber (345D). The walls (322, 502) together with the second portion of the inner wall surface (314) of the outer annular wall (310) define a plug chamber (424). Enough to adjoin the floor (484) of the tray (416B) when the tray (416B) is received within the rear portion of the tissue specimen chamber (345D) as described above for the fourth version. To length, a rib (504) extends from the inner surface of the wall (324) toward the first portion of the inner wall surface (314). Further, the tray (416B) includes a single protrusion rather than two protrusions, and a plurality of bins (506) disposed between the end wall (476) and the arcuate wall (482). The tray (416B) is similar to the tray (416A) described above for the fourth version. Further, each tissue specimen receiving space (492) of the tray (416A) was sized to receive only a single tissue specimen, whereas the tissue specimen receiving space (492) of the tray (416B). Is sized to accept several tissue specimens.

VIII. Exemplary Fifth Version of Inner Housing for Tissue Specimen Holder FIGS. 17-18 illustrate another exemplary inner housing (304E) for tissue specimen holder (300) of biopsy device (10). Indicates the version. The reference numerals used for similar components in previous versions of the inner housing (304A, 304B, 304C, 304D) are also used for the inner housing (304E). Furthermore, the similarities between the versions in this specification will not be further described.

  Inner housing (304E) includes a tray receiving chamber (345E) or a tissue specimen chamber configured to receive tray (416B). The tray (416B) is similar to the single-projection tray (416B) received in the inner housing (304D) and will not be further described.

  Referring to FIG. 17, a plug chamber (424) is defined at the proximal end within the wall (600) disposed between the first and second tissue specimen chambers (345E). A third tissue specimen chamber (345E) is disposed between the first and second tissue specimen chambers (345E) and separated from the first and second tissue specimen chambers (345E) by walls (602, 604). . Each of the walls (600, 602, 604) extends between an inner annular wall (606) and an outer annular wall (310). The ledge (608) extends laterally from the central portion of the inner annular wall (606) and extends distally to the annular extension (610) and the vertical extension (612) to the floor (614). And. Similar to the fourth version, and as shown in FIG. 18, a post (464) protrudes distally from the floor (614). Referring to FIG. 18, which shows a distal view of the inner housing (304E), the tissue specimen chamber (345E) and the plug chamber (424) include an anterior portion (F) and a posterior portion (R). The distal end of the wall (600, 602, 604) includes a protrusion (336) as previously described in previous versions. The ribs (616) perpendicular to the inner wall surface (314) of the outer annular wall (310) to a distance similar to the distance at which the protrusions (336) are positioned on the respective walls relative to the inner annular base (618). ) Projecting from the inner annular base (618). The rib (616) includes a T-shaped profile with an inner portion extending perpendicularly from an inner annular base (618) disposed below the floor (614) with an end adjacent to the inner portion. , Having a width greater than the width of the inner portion. Referring again to FIG. 17, the end of the rib (616) extends distally from a protrusion (620) disposed on the inner annular wall (606). The space defined by the rib (616), the back side of the ledge (608), and the annular base wall (622) extending between the inner annular base (618) and the floor (614), and the walls (600, 602) 604), the back side of the ledge 608, and the space defined by the at least one rib 616 operate as described above for the fluid receiving space of the previous example. It is.

  Any patents, publications, or other disclosure materials that are said to be incorporated herein by reference may, in whole or in part, be existing definitions, statements, or It should be understood that it is incorporated herein only to the extent that it does not conflict with other disclosure materials. Accordingly, to the extent necessary, the disclosure expressly set forth herein shall supersede any conflicting material incorporated herein by reference. Any document or portion thereof that is said to be incorporated herein by reference, but that conflicts with the existing definitions, statements, or other disclosure materials described herein, It is only incorporated to the extent that there is no discrepancy with the disclosure material.

  Embodiments of the present invention have application in conventional endoscopes and open surgical instrumentation, as well as in robot-assisted surgery.

  The device embodiments disclosed herein may be designed to be discarded after a single use, or may be designed to be used multiple times. In any case, or in any case, embodiments can be reconditioned for reuse after at least one use. Reconditioning can include any combination of device disassembly steps followed by cleaning or replacement of specific parts and subsequent reassembly steps. In particular, device embodiments may be disassembled, and any number of particular parts or portions of the device can be selectively replaced or removed in any combination. Once a particular part has been cleaned and / or replaced, the device embodiment can be reassembled for subsequent use at a reconditioning facility or by a surgical team immediately prior to a surgical procedure. One skilled in the art will recognize that reconditioning of the device can utilize various techniques for disassembly, cleaning / replacement, and reassembly. The use of such techniques and the resulting reconditioned device are all within the scope of this application.

  By way of example only, the embodiments described herein may be processed before surgery. First, a new or used instrument can be obtained and cleaned if necessary. The instrument can then be sterilized. In one sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and instrument can then be placed in a radiation field that can penetrate the container, such as gamma radiation, x-rays, or high energy electrons. Radiation can kill bacteria on the instrument and in the container. The sterilized instrument can then be stored in a sterile container. The sealed container can keep the instrument sterile until it is opened in the medical facility. The device can also be sterilized using any other technique known in the art, including but not limited to beta or gamma radiation, ethylene oxide, or steam.

  While various embodiments of the present invention have been illustrated and described, further modifications of the methods and systems described herein may be achieved by appropriate modifications by those skilled in the art without departing from the scope of the invention. obtain. Some of these potential modifications are mentioned, others will be apparent to those skilled in the art. For example, the above-described examples, embodiments, external shapes, materials, dimensions, ratios, processes, and the like are illustrative and not essential. Accordingly, the scope of the present invention should be considered in terms of the following claims and is understood not to be limited to the details of construction and operation shown and described herein and in the drawings.

Embodiment
(1) In the biopsy device,
(A) a probe body;
(B) a needle portion extending distally from the probe body and including a sideways tissue receiving hole;
(C) a hollow cutter positioned within the needle portion, translatable within the needle portion to cut a tissue specimen from tissue protruding through the hole, and defining a cutter lumen; With a hollow cutter,
(D) a tissue specimen holder,
(I) at least two tissue specimen chambers and at least one plug chamber, each chamber extending in an axial direction, the axial direction being parallel to the cutter lumen, and the at least one plug chamber being At least two tissue sample chambers and at least one plug chamber configured to receive a plug when at least one of the tissue sample chambers is configured to receive a tissue sample;
(Ii) at least one tray removably engaged with at least one of the tissue specimen chambers, wherein the at least one tray is axially removable from the tissue specimen chamber;
Including a tissue specimen holder, and
Including
The biopsy device, wherein the tissue specimen holder is operable to selectively index a tissue specimen chamber relative to the cutter lumen and receive the tissue specimen within the indexed chamber.
(2) In the biopsy device according to Embodiment 1,
The tissue specimen holder further comprises an inner housing;
The inner housing defines the chamber;
The biopsy device, wherein the at least one tray is removably engageable with at least one of the at least two tissue specimen chambers of the inner housing.
(3) In the biopsy device according to Embodiment 1,
The at least one tray includes at least one protrusion;
The projection includes a pair of side walls, a base end wall extending between each pair of side walls, and a floor integral with each pair of side walls and a corresponding base end wall.
(4) In the biopsy device according to Embodiment 3,
A biopsy device, wherein one of the at least two tissue specimen chambers is sized to receive the at least one protrusion of the tray.
(5) In the biopsy device according to Embodiment 3,
The tray includes at least a first protrusion and a second protrusion;
The tissue specimen holder includes at least a first chamber and a second chamber;
A biopsy device wherein the first tissue specimen chamber is sized to receive the first protrusion and the second tissue specimen chamber is sized to receive the second protrusion. .

(6) In the biopsy device according to Embodiment 1,
A biopsy device, wherein at least a portion of the tissue specimen holder is sized to fit within a formalin cup.
(7) In the biopsy device according to Embodiment 1,
Each tray includes at least one protrusion, each protrusion defining a tissue specimen receiving space;
A biopsy device, wherein each tissue specimen receiving space of each protrusion is associated with a corresponding tissue specimen chamber.
(8) In the biopsy device according to Embodiment 1,
The biopsy device, wherein the tissue specimen holder is configured to redirect fluid delivered to the cutter lumen from a first direction to a second direction.
(9) In the biopsy device according to Embodiment 1,
The tissue specimen holder is selectively engageable with the probe body;
The biopsy device, wherein the tissue specimen holder includes a release mechanism operable to selectively release the tissue specimen holder relative to the probe body.
(10) In the biopsy device according to Embodiment 1,
One of the at least two tissue specimen chambers defines a first chamber having a first volume, and the other of the at least two tissue specimen chambers has a second volume. Define
The first capacity is a biopsy device different from the second capacity.

(11) In the biopsy device according to embodiment 10,
The biopsy device, wherein the first volume is substantially larger than the second volume.
(12) In the biopsy device according to embodiment 11,
The biopsy device, wherein the first chamber is a bulk chamber configured to receive a plurality of tissue specimens.
(13) In the biopsy device according to embodiment 12,
The biopsy device, wherein the second chamber is configured to receive only a single tissue specimen.
(14) In the biopsy device according to embodiment 12,
The biopsy device, wherein the second chamber is configured to receive at least one tissue specimen less than the bulk chamber.
(15) In the biopsy device according to embodiment 1,
The biopsy device, wherein the tissue specimen holder is configured to redirect fluid from the cutter lumen to a vacuum lumen.

(16) In a tissue specimen holder configured to engage a biopsy probe and receive a tissue specimen,
(A) A housing including at least a first chamber and a second chamber, each of the chambers extending along an axial direction, the first chamber having a first capacity, and the second chamber The chamber has a second volume, the first volume being different from the second volume, a housing;
(B) at least one tray configured to be axially received within at least one of the chambers and configured to receive a tissue specimen;
Including a tissue specimen holder.
(17) In the tissue specimen holder according to embodiment 16,
The housing is
(I) an outer member having a proximal edge and a distal edge and defining a central bore;
(Ii) a plurality of radially extending walls extending from the outer member;
(Iii) An inner member extending between inner ends of the plurality of radially extending walls, the inner end being spaced from the outer member, the outer member, the inner member, and the wall An inner member defining at least one of the at least two tissue specimen chambers;
Further including
A first portion of the outer member, the inner member, a first outer wall of the plurality of walls, and a second outer wall of the plurality of walls define a first chamber;
A second portion of the outer member, the inner member, and at least two of the plurality of walls define a second chamber of the at least two chambers;
The tissue sample holder, wherein the first chamber is separated from the second chamber.
(18) In the tissue specimen holder according to embodiment 17,
Each of the chambers includes a proximal end and a distal end;
The proximal end is configured to receive a tray;
The distal end is configured to be positioned proximate to the probe;
The tissue specimen holder, wherein the plurality of radially extending walls of the housing extend between the proximal end and the distal end.
(19) In the tissue specimen holder according to embodiment 17,
The at least one tray is
(I) a pair of sidewalls each having a proximal edge and a distal edge;
(Ii) a base end wall engaging the side wall, the base end wall having a proximal edge and a distal edge and defining a hole;
(Iii) a floor connected to the proximal edge of the side wall and the proximal edge of the base end wall;
Including
The tray is configured to be received within one of the at least two tissue specimen chambers such that the distal edge of the side wall of the tray is received within the respective chamber. Constructed, tissue specimen holder.
(20) A method of operating a biopsy device, wherein the biopsy device is configured to (i) a needle having a tissue receiving hole and defining a needle axis, and (ii) cutting tissue in the hole. And (iii) a lumen configured to deliver tissue cut by the cutter, and (iv) an inner housing for a tissue specimen holder having a bulk chamber and a tray chamber, the bulk chamber Wherein the tray chamber has at least one tray configured to receive tissue delivered through the lumen via an entry point, wherein the tray chamber has a larger capacity than the tray chamber.
(A) capturing a tissue specimen with the needle and the cutter;
(B) sending the tissue specimen through the lumen to the bulk chamber via the entry point;
(C) rotating the inner housing to change the position of the inner housing relative to the entry point;
(D) repeating steps (a) to (c) until the tray is placed on the entry point;
(E) sending a tray tissue specimen through the lumen to the tray via the entry point;
(F) removing the tray from the tissue specimen holder by pulling the tray in an axial direction parallel to the needle axis;
Including the method.

1 is a schematic diagram of an exemplary biopsy system. FIG. FIG. 4 is a schematic block diagram illustrating various components of an exemplary biopsy device. FIG. 2 is a perspective view of an exemplary biopsy device holster and probe coupled to each other, the probe including a tissue specimen holder. FIG. 4 is a perspective view of the biopsy device of FIG. 3 showing the probe separated from the holster so as to expose the back side of the probe and the top side of the holster. FIG. 4 is an end view of an embodiment of an inner housing for the tissue specimen holder of FIG. 3 attached to the end of the probe of FIG. 3, wherein the tissue specimen entry point of the probe, a bulk chamber inside the inner housing, and the inner housing interior Figure 2 shows a tray receiving chamber of FIG. 6 is a perspective view of the proximal end of a removable tray received in the inner housing of FIG. 5 and the tray receiving chamber of FIG. FIG. 7 is a perspective view of the distal end of the inner housing and removable tray of FIG. FIG. 7 is an exploded perspective view of the inner housing and removable tray of FIG. 6. FIG. 4 is an end view of another embodiment of the inner housing for the tissue specimen holder of FIG. 3 attached to the end of the probe of FIG. 3, wherein the tissue specimen entry point of the probe, the bulk chamber inside the inner housing, and the inner housing Figure 5 shows the internal tray receiving chamber. FIG. 10 is a perspective view of the distal end of a removable tray received in the inner housing of FIG. 9 and the tray receiving chamber of FIG. FIG. 11 is an exploded perspective view of the inner housing and removable tray of FIG. 10. FIG. 4 is a perspective view of the proximal end of another embodiment of an inner housing for the tissue specimen holder of FIG. 3. FIG. 13 is an exploded view of the tissue specimen holder of FIG. 3, showing the inner housing, two-projection tray, marker and / or drug seal plug, bulk chamber cap, gear shaft, and outer cap of FIG. FIG. 14 is an assembled perspective view of the tissue specimen holder of FIG. 13. FIG. 4 is a perspective view of the proximal end of another embodiment of an inner housing for the tissue specimen holder of FIG. 3. FIG. 17 is an exploded view of the tissue specimen holder of FIG. 3, showing the inner housing, one-projection tray, marker and / or drug seal plug, bulk chamber cap, gear shaft, and outer cap of FIG. FIG. 4 is a perspective view of the proximal end of another embodiment of an inner housing for the tissue specimen holder of FIG. 3. FIG. 18 is an exploded view of the tissue specimen holder of FIG. 3 showing the inner housing, multiple single-projection trays, marker and / or drug seal plug, bulk chamber cap, and gear shaft of FIG.

Claims (17)

In the biopsy device,
(A) a probe body;
(B) a needle portion extending distally from the probe body and including a sideways tissue receiving hole;
(C) a hollow cutter positioned within the needle portion, translatable within the needle portion to cut a tissue specimen from tissue protruding through the hole, and defining a cutter lumen; With a hollow cutter,
(D) a tissue specimen holder,
And at least two tissue specimens Chang Ba (i), each of said chambers, extending in the axial direction, the axial direction, the parallel and lumen cutter, at least two tissue specimens Chang Bas,
(Ii) at least one tray removably engaged with at least one of the tissue specimen chambers, wherein the at least one tray is axially removable from the tissue specimen chamber;
Including a tissue specimen holder, and
Including
The at least two tissue specimen chambers include a first chamber and a second chamber; the first chamber defines a first volume; the second chamber defines a second volume; The first capacity is substantially larger than the second capacity;
The tissue sample holder, a tissue sample chamber selectively indexed to the cutter lumen, Ri operatively der to receive the tissue sample to indexing has been said chamber,
The tissue specimen holder passes through at least two angular positions, including a first angular position at which the first chamber is indexed and a second angular position at which the second chamber is indexed; A biopsy device operable to selectively rotate the at least two tissue specimen chambers . The biopsy device according to claim 1,
The tissue specimen holder further comprises an inner housing;
The inner housing defines the chamber;
The biopsy device, wherein the at least one tray is removably engageable with at least one of the at least two tissue specimen chambers of the inner housing. The biopsy device according to claim 1,
The at least one tray includes at least one protrusion;
The projection includes a pair of side walls, a base end wall extending between each pair of side walls, and a floor integral with each pair of side walls and a corresponding base end wall. The biopsy device according to claim 3,
A biopsy device, wherein one of the at least two tissue specimen chambers is sized to receive the at least one protrusion of the tray. The biopsy device according to claim 3,
The tray includes at least a first protrusion and a second protrusion ;
A biopsy device wherein the first tissue specimen chamber is sized to receive the first protrusion and the second tissue specimen chamber is sized to receive the second protrusion. . The biopsy device according to claim 1,
The biopsy device, wherein the tissue specimen received in the second chamber of the tissue specimen holder is a pathological specimen for further testing . The biopsy device according to claim 1,
Each tray includes at least one protrusion, each protrusion defining a tissue specimen receiving space;
A biopsy device, wherein each tissue specimen receiving space of each protrusion is associated with a corresponding tissue specimen chamber. The biopsy device according to claim 1,
The tissue sample holder, and negative air pressure to draw fluid in communication with the cutter lumen to said tissue sample holder, and the positive air pressure for removing fluid communicating with the cutter lumen from the tissue sample holder A biopsy device configured to selectively provide a biopsy device. The biopsy device according to claim 1,
The tissue specimen holder is selectively engageable with the probe body;
The biopsy device, wherein the tissue specimen holder includes a release mechanism operable to selectively remove the tissue specimen holder relative to the probe body. The biopsy device according to claim 1 ,
It said first chamber, Ru is configured to receive a plurality of tissue samples, biopsy device. The biopsy device according to claim 10 ,
The biopsy device, wherein the second chamber is configured to receive only a single tissue specimen. The biopsy device according to claim 10 ,
The biopsy device, wherein the second chamber is configured to receive at least one less tissue specimen than the first chamber. The biopsy device according to claim 1,
The biopsy device, wherein the tissue specimen holder is configured to direct fluid from the cutter lumen to a vacuum lumen. In a tissue specimen holder configured to engage a biopsy probe and receive a tissue specimen,
(A) A housing including at least a first chamber and a second chamber, each of the chambers extending along an axial direction, the first chamber having a first capacity, and the second chamber The chamber has a second volume, the first volume being different from the second volume, a housing;
(B) at least one tray configured to be axially received within at least one of the chambers and configured to receive a tissue specimen;
Only including,
The tissue specimen holder is operable to selectively index a chamber and receive the tissue specimen within the indexed chamber;
The tissue specimen holder passes through at least two angular positions, including a first angular position at which the first chamber is indexed and a second angular position at which the second chamber is indexed; A tissue specimen holder operable to selectively rotate the housing . The tissue specimen holder according to claim 14 ,
The housing is
(I) an outer member having a proximal edge and a distal edge and defining a central bore;
(Ii) a plurality of radially extending walls extending from the outer member;
(Iii) An inner member extending between inner ends of the plurality of radially extending walls, the inner end being spaced from the outer member, the outer member, the inner member, and the wall An inner member defining at least one of the at least two tissue specimen chambers;
Further including
A first portion of the outer member, the inner member, a first outer wall of the plurality of walls, and a second outer wall of the plurality of walls define a first chamber;
A second portion of the outer member, the inner member, and at least two of the plurality of walls define a second chamber of the at least two chambers;
The tissue sample holder, wherein the first chamber is separated from the second chamber. The tissue specimen holder according to claim 15 ,
Each of the chambers includes a proximal end and a distal end;
The proximal end is configured to receive a tray;
The distal end is configured to be positioned proximate to the probe;
The tissue specimen holder, wherein the plurality of radially extending walls of the housing extend between the proximal end and the distal end. The tissue specimen holder according to claim 15 ,
The at least one tray is
(I) a pair of sidewalls each having a proximal edge and a distal edge;
(Ii) a base end wall engaging the side wall, the base end wall having a proximal edge and a distal edge and defining a hole;
(Iii) a floor connected to the proximal edge of the side wall and the proximal edge of the base end wall;
Including
The tray is configured to be received within one of the at least two tissue specimen chambers such that the distal edge of the side wall of the tray is received within the respective chamber. Constructed, tissue specimen holder.

Images